MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT ENDOPROSTHESIS; CATHETER, BILIARY, DIAGNOSTIC

Model Number	26280
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent was not fully reconstrained.A 16x90/9 fr uni plus 75cm wallstent endoprosthesis stent self expanding catheter was advanced for treatment.However, as they pulled the sheath back to deliver the stent, the stent slid back with the sheath.The stent was reconstrained; however a part was still exposed at the time of removal from the patient.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8831765
• Report Number: 2134265-2019-08722
• Device Sequence Number: 18887434
• Product Code: MAF
• UDI-Device Identifier: 08714729204053
• UDI-Public: 08714729204053
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K152842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/19/2021
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0023511711
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 07/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR